DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment submitted 1/7/2026 is acknowledged. Claims 155-166 and 168-175 are canceled. New claims 309-328 are added.
Election/Restrictions
Applicant’s election of the required species, SEQ ID NO: 38, in the reply filed on 1/7/2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 312-313 and 317-328 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/7/2026.
Claims 309-311 and 314-316 are under examination on the merits.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on 1/18/2024 and 12/20/2024 are in compliance with 37 CFR 1.97. Accordingly, the IDSs are being considered by the examiner.
Drawings
The drawings are objected to because Figure 4 lists peptides by their sequence but fails to provide sequence identifiers. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on p. 84 (para. [0233]) and 86 (para. [0241]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 309 is objected to because of the following informalities: it appears to have a typographical mistake, where it recites “An AAV capsid protein comprising an AAV capsid protein comprising” on 1, which is a duplication. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 309 and 310 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
MPEP 2173.05(s) states:
[Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim. See MPEP § 608.01(m) for information pertaining to the treatment of reference characters in a claim.] Presently, the claimed information of Tables 1, 4-30, and FIG. 4 of claims 309 and 310 do not meet the requirements of an “exceptional circumstances where there is no practical way to define the invention in words”. Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 309-311 and 314-316 are rejected under 35 U.S.C. 103 as being unpatentable over Kurtzman (PGPub US 20020102243 A1, published 8/1/2002, filed 5/16/2001) in view of Nieto (PLoS One. 2012;7(6):e39741. doi: 10.1371/journal.pone.0039741. Epub 2012 Jun 27. PMID: 22761884), Poehlein (Genome Announc. 2016 Jun 23;4(3):e00617-16. doi: 10.1128/genomeA.00617-16. PMID: 27340077), and Nguyen-Hieu (APMIS. 2013 Jun;121(6):467-77. doi: 10.1111/apm.12015. Epub 2012 Oct 19. PMID: 23078250).
The Prior Art
Kurtzman discloses immunization methods using recombinant viral vectors (Abstract), wherein AAV vectors include a first nucleic acid sequence that encodes an antigen or an allergen (paras. [0129-0135]. Kurtzman also discloses that antigens will preferably be of an intracellular pathogen, such as a viral, bacterial, or parasitic pathogen, but the invention is not limited to a particular antigen (para. [0135]). However, Kurtzman does not teach SEQ ID NO: 38 or an AAV capsid protein comprising an insert sequence at least 71.4% identical to SEQ ID NO: 38.
Nieto discloses empty AAV2 particles (AAVLPs), assembled from VP3 alone, for display of HPV L2 epitopes to enhance their immunogenicity, which harbored insertions of neutralizing epitopes into VP3 at positions 587 and 453, thereby permitting assembly of VP3 into empty AAV particles (Fig. 1A; Abstract). Nieto further discloses that AAVLPs represent a preferred scaffold for peptide vaccination because of their simplicity and their inability to transfer genes, and allow a highly structured and repetitive presentation of epitopes on the capsid (60 times), so potent B-cell responses against the peptide presented at immunogenic capsid positions can be expected (p. 2, col. 1, para. 1).
Poehlein discloses a genome sequence of Methanobrevibacter oralis, an archaea isolated from the human subgingival plaque (p. 1, col. 1, paras 1; Table 1). Methanobrevibacter oralis encodes a sequence that has a domain identical to instant SEQ ID NO: 38, see alignment below:
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Nguyen-Hieu discloses that Methanobrevibacter oralis is a periodontal pathogen (Abstract).
It would have been obvious to one of ordinary skill in the art to modify the vaccination strategy taught by Kurtzman to include AAV bearing antigens inserted into AAV capsid VP3, wherein the inserted peptide is SEQ ID NO: 38. Poehlein discloses that SEQ ID NO: 38 is part of a Methanobrevibacter oralis protein, and Nguyen-Hieu discloses that Methanobrevibacter oralis is a pathogen. Because Methanobrevibacter oralis is a pathogen, it would be obvious to one of ordinary skill in the art that any peptide derived from one of its proteins could potentially be antigenic and serve to raise an immune response against Methanobrevibacter oralis. One of ordinary skill in the art would have been motivated to vaccinate against Methanobrevibacter oralis. There would be a reasonable expectation of success because Nieto discloses AAVLPs represent a preferred scaffold for peptide vaccination because of their simplicity and their inability to transfer genes, and allow a highly structured and repetitive presentation of epitopes on the capsid (60 times), so potent B-cell responses against the peptide presented at immunogenic capsid positions can be expected . Therefore, claims 309-311 and 314-316 were prima facie obvious before the priority date of the instant invention.
Conclusion
No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY MARK SIFFORD whose telephone number is (571)272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671
/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671